Links to regulatory frameworks

Safety assessment has to be linked to one or several regulatory frameworks. Information about criteria from these frameworks will be used on Analysis stage of safety assessment.

To link safety assessment to regulatory framework, click right mouse button on the safety assessment icon in object browser and select Link regulatory framework from context menu. In the Select regulatory framework window which is displayed, select regulatory framework and press Link selected object.

Note: If list of regulatrory frameworks in Select regulatory framework window is empty then:

• The safety assessment is alrteady linked to all available regulatory frameworks

or

• There are no regultory frameworks defined. In this case, user need to ceate regulatory framewor using either object browser or tab “Tree view” of the Select regulatory framework window.